MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-4-HX-ES
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that an axium coil prematurly detached from non detachment.After inserting the product into the aneurysm in a patient with a subarchnoid hemorrhage (sah), the attempted to detach the product with the corresponding id-1-5, but the withdrawal was not completed.When a second withdrawal failed, early detachment occurred during attempts to retrieve it.Thrombosis occurred, but it was overcome with medication and other means.The coil was attached to the blood vessel with a stent.The coil was placed and adhered to the blood vessel using a stent.The coil remains in patient.It is not placed at the intended location.Medical intervention was required.There was no damage or deformation to the delivery pusher.There was no resistance during delivery.The coil was repositioned 1 time.The physician attempted to detach the coil 3 times with the instant detacher.The delivery pusher was not rotated inside the patient's body.Continuous flush was administered during the procedure.The device was prepared as indicated in the package insert.The patient was being treated for a ruptured, saccular aneurysm in the internal carotid cave 5mm.The max di ameter was 5mm and the neck diameter was 3mm.Blood flow speed was normal and vessel tortuosity was moderate.No patient symptoms were reported.
Event or Problem Description
Additional information received reported that the patient did not experience any particular problems following the thrombosis.After the onset of the thrombosis, the addition of effient was performed.The coil remained in the patient.The part that deviated from the mother blood vessel was adhered with a stent.The deviation part was not in the intended located, but there were no difficulties due to the stent.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19076463
• Report Number: 9612164-2024-01682
• Device Sequence Number: 17607207
• Product Code: KRD
• UDI-Device Identifier: 00847536021006
• UDI-Public: 00847536021006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2024
• Device Model Number: APB-2-4-HX-ES
• Device Catalogue Number: APB-2-4-HX-ES
• Device Lot Number: 223386490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female